The field of the invention relates generally to oral devices. More specifically, the invention relates to mouthpieces and oral appliances for use in clinical, diagnostic, and imaging tests for the study, diagnosis, and treatment of breathing disorders. The invention can also be used in conjunction with devices that measure pulmonary function such as spirometry-type devices. The invention may also be used with airway resistance measurement devices. The device may also be used in connection with other imaging techniques for the upper airway region.
Sleep related breathing disorders (SBD's) adversely affect the breathing of individuals during periods of sleep. Breathing disruption in sleep often results from the collapse or closing of an individual's air passageway. Sleep apnea, as one common example of a SBD, is an abnormal physical condition that affects a person's ability to breath properly after falling asleep. Persons suffering from sleep apnea can stop breathing for periods as short as a few seconds and as long as a few minutes.
Typically, SBD's such as sleep apnea are treated by Continuous Positive Air Pressure (CPAP) therapy. In CPAP therapy, a device that is essentially an air pump forces air into an individuals air passageway. The CPAP device maintains sufficient pressure to keep the air passageway open during periods of sleep. The patient typically wears a mask-like device that is connected to the CPAP device to provide the elevated air pressure into the upper air passageway. Other devices known as BiPAP (Bi-Level Positive Airway Pressure) devices operate at two positive air pressure levels. A lower pressure level is used during patient exhalation while a higher pressure level is used during inhalation. The BiPAP devices make it easier to exhale due to the lower pressure used during exhalation. BiPAP devices are often proscribed for individuals that require higher pressures than those present in CPAP devices.
For many individuals that suffer from a SBD, CPAP and BiPAP therapy are not appropriate. A significant portion of these individuals, however, may be treated successfully with oral appliances. An oral appliance is a device that is positioned with a patient's mouth to correct the diagnosed problem or condition. One example of an oral appliance is the intra-oral appliance described in U.S. Pat. No. 5,868,138 issued to Halstrom. U.S. Pat. No. 5,868,138 is incorporated by reference as if set forth fully herein. The device may, for example, alter the position of the patient's jaw to open-up the patient's airway.
When using oral appliances, it is necessary to determine the efficacy of such appliances through the use of diagnostic tests or studies. In this regard, the appropriate type of appliance for a particular patient can be chosen. In addition, the optimal characteristics of an individual oral appliance is readily obtainable. Typically, the diagnostic studies or tests measure the cross-sectional area (CSA) in the pharynx region of the patient. These tests permit clinicians to determine the effect of the oral appliance on the CSA. One technique that measures CSA includes acoustic pharyngometry (AR).
Unfortunately, there are several limitations to the accuracy and repeatability of these tests in measuring CSA. First, the position of the tongue can significantly impact CSA readings in the upper airway. Proper tongue placement is critical for upper airway assessments because the base of the tongue defines the anterior wall of the oropharynx. Minor movements of the tongue can significantly skew the CSA data, making diagnosis difficult.
Separate and apart from the tests that measure CSA, there are still other pulmonary tests and diagnostic methods that require proper placement of the tongue and jaw. Spirometry, for example, is one pulmonary test that can be adversely effected by improper placement of the tongue or jaw. Like the tests that measure CSA, improper placement of the tongue and/or jaw can adversely effect the accuracy and repeatability of these other tests.
In the case of acoustic pharyngometry, medical technologists are charged with the task of coaching patients on proper tongue placement. Because it is impossible to directly observe the position of the tongue in the patient's mouth, the medical technologist must instruct the patient to move their tongue into the proper position (ideally, down and forward in the mouth). The medical technologist must then interpret the data to determine whether the patient has, in fact, achieved proper tongue placement. The technologist generally looks for artifacts that are created in the test results. This, however, is problematic because artifacts are difficult to identify. Moreover, there is no standard or baseline that is consistent across different individuals because the size and structure of the mouth varies between individuals. This further complicates the job of the medical technologist.
As with the tongue, the position of the jaw can also affect the CSA. Different jaw positions can create artifacts in the test results.
Accordingly, there is a need for a device that permits an individual to stabilize the placement of the tongue during diagnostic examination. The device preferably permits accuracy and repeatability in clinical, diagnostic, and imaging tests by stabilizing movement of both the tongue and jaw. The device would further permit the insertion of imaging probes and diagnostic devices into the oral cavity while the device is in place. In this regard, the efficacy of the oral appliance would be accurately measured without being adversely impacted by artifacts.
In addition to being used in diagnostic examinations, the tongue positioning mechanism can also be used in the actual oral appliances that are used by a patient. In this regard the oral appliance gives optimal placement of the tongue within the oral cavity.
Moreover, the device, when used as a mouthpiece, preferably can include an optional filter that would eliminate the need to disinfect testing or diagnostic devices between patient uses.